17 judgments of the Delhi High Court, the Madras High Court and 1 other court applying Patents Act s.3(i), from 2023–2025, each with a headnote by BRB Legal.
Appeal allowed and the application directed to proceed to grant, the exclusion for diagnostic processes under section 3(i) being held inapplicable. The judgment is also useful on amendments: the amended claim added a limitation that the infrared beam diameter be equal to or larger than the hydrophilic region, which had not appeared in the originally filed claims. The Court held the amendment permissible under section 59 because the feature was expressly present as a preferred embodiment at paragraph 23 of the complete specification, which explained why the relationship was needed for accurate quantitation, and because it narrows rather than expands the claim. It therefore qualified as an explanatory amendment incorporating an actual fact, adding no new matter and not changing scope.
Appeal dismissed, the application for a method of detecting single nucleotide variants from blood samples being held to fall within the exclusion for diagnostic methods under section 3(i). Having so held, the Court expressly declined to go into the Patent Office's views on inventive step or section 59. It added that whether such an embargo ought to exist in order to enable innovation in biotechnology is a question of policy beyond its remit.
Two appeals dismissed on section 3(i). The Court held that the fact a method is performed in vitro does not by itself make it patentable so long as the purpose of the process is to diagnose a medical condition: here the method of methylation of samples drawn from a pregnant woman produced a result sufficient to eliminate her from further testing, which brought it within the exclusion. Grants of the same invention in foreign jurisdictions could not displace the statutory prohibition in India. As the second application differed from the first only in the polynucleotide sequences, the analysis in the first bound the appellants in both.
Interim injunction granted restraining a biosimilar of Nivolumab during the pendency of the suit. The Court weighed that the patent was valid in fifty countries and had been sustained against challenge in thirty, that it had been granted only after fourteen years, which itself shortened the limited monopoly, that a pre-grant opposition by an association of which the defendant is a member had been rejected, and that the defendant had been under injunction for more than a year and had no manufacturing licence until December 2024.
Appeal dismissed and a refusal upheld on section 59(1). The unamended claims were directed to a method of treatment, excluded under section 3(i) and failing the industrial application requirement of section 2(1)(j), and the proposed amendments went beyond disclaimer, correction or explanation. The Court distinguished Allergan, where amendment of method of treatment claims to product claims had been allowed, on the footing that the decision there did not address whether the amendment fell within the limited permitted categories and that the amended claims concerned the same disease as the original; here the original claims and specification referred to a specific disease while the amended claims referred to none, so the amendment broadened rather than narrowed the scope.
Refusal set aside and the application for a method of controlling infestation of rice plants remanded. The 2002 amendment removed the words or plants from section 3(i), the object being to lift the bar on patenting methods for the treatment of plants. Agreeing with the Calcutta High Court in Decco Worldwide, the Court held that a method of treatment of plants does not fall within method of agriculture under section 3(h) either, since the legislature cannot have intended to remove the bar under one provision and reintroduce it under the other. None of the exclusions illustrated in the Manual of Patent Office Practice and Procedure, such as producing a plant, producing mushrooms or removing weeds, covers treatment of plants.
Section 3(i) has two distinct and self-contained limbs, and the second deals only with animals: a process for the similar treatment of animals is excluded only where it is to render them free of disease, to increase their economic value, or to increase the economic value of their products. On that reading, a method of generating antibodies carrying human variable regions in genetically modified mice falls outside the exclusion. It does not treat the mice for disease, does not raise their sale value, and the antibodies are not products of the mice: meat, hair, skin and milk are intrinsic parts or secretions of an animal, whereas these antibodies are raised in response to antigens administered after the genome had been substantially modified, and non-murine antibodies are not products of a mouse. Section 3(i) being the only ground of refusal, grant was directed.
The refusal rested almost entirely on judgements of the Court pronounced some six months after the hearing and the written submissions, which the applicant had therefore never had the chance to address. That alone warranted interference, with no opinion expressed on whether the claimed invention per se discloses pathology.
A refusal under section 3(i) was set aside where the claim was to an in vitro method of selecting an allogenic T cell line for later therapeutic administration, and not to a method of treatment at all. The distinction between a method of treatment and a method of producing or selecting a substance is what decides these cases, and the Controller had not drawn it.
Refusal under sections 3(i) and 3(j) set aside. The claim had been amended from a transgenic non-human mammal to a nucleic acid molecule, which took the section 3(j) objection away, yet the Controller never discussed the amended claims and merely extracted the claims as filed and at the First Examination Report stage. The section 3(j) objection had not been raised at the earliest point in any event. On section 3(i) the order concluded the invention was only a vaccination method with no discussion or reasoning at all, and on inventive step neither discussion nor reasons were given. Since nucleic acid was clearly disclosed in the specification, the amendment was not beyond the scope of the original claim and section 59 could not be held against the applicant.
Refusal under sections 3(e) and 3(i) set aside. The section 3(e) objection never appeared in the hearing notice, and the Court reiterated its consistent position that the Controller must enumerate all pending objections there, a requirement also carried by Circular No. 4 of 2011. Omitting it deprived the applicant of the chance to answer and violated natural justice. On section 3(i), claim 1 was a product claim naming no disease, no treatment and no mode of administration, so a provision directed at methods of treatment did not apply. The scope of a patent is set by the claims, read in light of the description; working examples demonstrate that an invention is feasible and workable but do not define its scope, so the mere recitation of unit numbers in the claim could not render it ineligible.
Unless an amendment exceeds the original specification within the meaning of section 59, it is obligatory on the Controller to allow it and then consider why the claim is not tenable. Section 59 may have no role at the point when amendments are sought; its role is post-amendment. Here the amendment was refused with no reason given at all.
Section 3(i) treats a process for the treatment of animals as a non-invention only where it is to render them free of disease, or to increase their economic value or that of their products. A composition for oral administration to cats with chronic renal disease, to restore appetite and weight, was never claimed as a permanent cure of any ailment, so the Controller had missed the critical limb of the provision.
Refusal under sections 3(i) and 3(j) set aside. Section 3(j) was never raised in the hearing notice yet became a ground of rejection, which denied the applicant any opportunity to contest it and breached natural justice. On section 3(i) the Court drew a distinction that decided the appeal: between a method of treatment and a method for producing a substance or composition which may have a specific use in a method of surgery, therapy or diagnosis. The claims here were to a method of producing a protein-enriched blood serum using gold particles, which is a method of producing a novel composition; the possible use of that serum in transfusion is an application of the product and was not part of the claims at all. Failing to recognise the distinction led to an erroneous application of the provision. The Court noted that the European Patent Office had granted the patent notwithstanding Article 53(c) of the European Patent Convention, which is to similar effect.
Appeal allowed and the application for fetal genomic analysis from a maternal sample directed to proceed to grant on amended claims 1 to 12. Determining fetal fraction, the proportion of cell free fetal DNA in the sample, is related to diagnosis but is not diagnostic within section 3(i), because the method cannot by itself identify the existence of a disease, disorder or condition and further testing is needed before pathology is uncovered. The scope of diagnostic should neither be curtailed to in vivo or definitive diagnosis nor expanded by implying the words relating to. The suggestion that the test might be used for sex determination was held irrelevant to patentability, that being a matter for the PNDT Act. Since section 3(i) was the only surviving objection, the application proceeded.
Appeal and writ petition dismissed and the refusal under section 3(i) upheld. The claimed method sequenced nucleic acid molecules from a maternal sample to determine their size distribution against reference values. The Court held that although the claims delimit the monopoly, the embodiments in the complete specification can and should be examined to decide whether a process is per se diagnostic, and those embodiments stated that a difference in size beyond a cutoff allows a diagnosis of fetal chromosomal aneuploidy to be made. A person skilled in the art could therefore arrive at a diagnosis by this process. Neither definitive nor comprehensive diagnosis is a prerequisite to being diagnostic, so it did not matter that a doctor would follow up with chorionic villi sampling or amniocentesis.
Refusal of a patent for a fungicidal treatment for black sigatoka was set aside and the application remanded. The finding that the invention lacked inventive step was unreasoned: the Controller compared prior art D1 to D7 without appreciating what they taught, left the applicant's written submissions unanswered, and did not apply the inventive step tests set out in Avery Dennison. The court restated that a specification is construed by reading the description of the invention before the claims, following Bishwanath Prasad Radhey Shyam.
